Earlier this year, Awakn Life Sciences announced impressive results of its Phase 2 trial using ketamine for alcohol use disorder – including 86% abstinence 6 months after treatment with no serious side effects. It was the kind of trial results the industry was hoping for and it helped put Awakn on many people’s radars.
A little after, Awakn announced a partnership with the legendary MAPS organization to explore licensing deals and use MDMA-assisted therapy to treat alcohol use disorder (AUD) in Europe. The company also has announced the approval of its third treatment clinica London clinic that will join their current clinics in Bristol (UK) and Oslo (Norway), giving the company access to revenue and preparing for future treatments of approved psychedelics, including ketamine treatments already approved.
We now have news of funding for its upcoming Phase 3 trial. The UK‘s National Institute for Health and Care Research (NIHR) has approved funding for a grant covering 66% of the costs of the Phase 3 clinical trial. III from Awakn exploring the use of ketamine-assisted therapy for the treatment of alcohol use disorder. The trial is currently expected to cost around C$3.75 million in total, with Awakn funding around C$1.25 million.
Starting a phase 3 trial in 2022 is big news, and getting the government-funded ⅔ of it is even better, especially since Awakn was short on funds, with less than 3 million in the bank since their last financial results.
Another important point of the press release:
“Awakn will partner with the University of Exeter (UoE) and the UK National Health Service (NHS) to deliver this landmark trial. It is planned to be carried out at seven sites in the UK, with the treatment being administered within the NHS infrastructure.
This announcement appears to solidify an already positive relationship with the UK government-run healthcare system, a potentially crucial development for Awakn’s future business plans.
See the full press release below.
The Phase III trial will cost approximately C$3.75 million, with Awakn’s contribution expected to be approximately C$1.25 million
This is the first phase III trial of psychedelics to receive government funding.
TORONTO, CANADA, July 20, 2022 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (“Awakn”), a revenue-generating biotechnology company that researches, develops and commercializes therapies to treat addiction with a near-term focus on addiction-related disorders. Alcohol Consumption (AUD), today announced that the National Institute for Health and Care Research (NIHR), a UK government agency, has approved a grant covering 66% of the costs of the clinical trial of phase III of Awakn exploring the use of ketamine-assisted therapy for the treatment of AUD. The trial is currently expected to cost around C$3.75 million in total, with Awakn funding around C$1.25 million.
The funding will support Awakn’s lead clinical development program, Project Kestrel, which aims to provide clear intellectual property (IP) and marketing clearance/regulatory approval for ketamine-assisted therapy to treat AUD in the UK and USA.
The Phase III trial is expected to be the largest ketamine-assisted therapy clinical trial to date and the only Phase III psychedelic clinical trial to receive government funding. Awakn will partner with the University of Exeter (UoE) and the UK National Health Service (NHS) to deliver this landmark trial. It is planned to be carried out at seven sites in the UK, with the treatment being administered within the NHS infrastructure. The trial is currently designed to include 280 patients and they will be followed over the course of six to 12 months. The trial will also pilot ongoing tailored peer support groups after treatment.
The trial, which aims to be a pivotal trial, follows groundbreaking results from Awakn’s study Phase II a/b trial announced in January 2022, resulting in AUD participants experiencing an average of 86% abstinence six months after treatment compared to 2% pre-trial. The Phase III trial will focus on establishing new, definitive evidence of the efficacy of ketamine-assisted therapy for the treatment of AUD and progressing to the new approved treatment for this indication. Awakn, UoE and the NHS will work with the UK Department of Health and Social Care and other key stakeholders throughout the trial to facilitate rapid uptake within the NHS after the trial, if the results are positive.
The phase III trial will be led by Professor Celia Morgan, head of ketamine-assisted therapy at Awakn and professor of psychopharmacology at the University of Exeter.
Professor Morgan commented: “It is a real honor to lead the team that will conduct this research. The essay represents a huge leap forward in the treatment of the AUD. I know this will be a source of great hope for the patients we work with, their families and their friends. The UK government’s financial commitment underscores the promise of this treatment and the scientific rigor behind the trial. This, coupled with carrying out the trial within NHS settings and working closely with regulators throughout, means that the likelihood of rapid uptake is very high, if the results of this trial live up to their early promise. .
Awakn chose AUD as its primary indication because it is a chronic disease constrained by a large treatment gap and poor current level of care. AUD allocates 400 million[1] people globally; with only 8% of people with the condition seeking treatment[2]and typically a 75% relapse rate within 12 months in those who have[3]. Despite this large processing gap and low efficiency, the US AUD processing market is valued at C$45 billion.[4]while the NHS in the UK spends over C$5.5 billion a year[5] on AUD-related diseases.
Anthony Tennyson, CEO of Awakn, commented: “We are pleased with today’s news for several reasons. A government that strongly supports this new type of treatment is a world first. Secondly, working with the NHS to deliver the treatment within its existing infrastructure is a huge statement of intent, but more importantly, for so many millions around the world suffering from alcohol dependence, new hope for treatment has just come a big step. ‘ closer. I couldn’t be more proud of the Awakn team and our partners for making this a reality.
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a revenue-generating biotechnology company that researches, develops and commercializes therapeutic products to treat addictions and behavioral addictions. Awakn’s short-term focus is on alcohol use disorder (AUD), a condition affecting 400 million people worldwide for which the current standard of care is inadequate. Our goal is to provide effective treatments to drug addicts who desperately need them and our strategy is focused on commercializing our R&D pipeline across multiple channels.
www.AwaknLifeSciences.com | Twitter | LinkedIn | Facebook | www.AwaknClinics.com
About the Kestrel Project
The Kestrel project is Awakn Life Sciences’ primary clinical development program. The Kestrel Project is supported by Awakn’s Phase II a/b “KARE” clinical trial which investigated ketamine-assisted therapy for the treatment of alcohol use disorder (AUD). The trial resulted in an average sobriety of 86% of patients 6 months after treatment compared to 2% before the trial, meaning that study participants went from sobriety on average 7 days per year to average sobriety 314 days a year. Awakn plans to initiate a phase III trial in the UK in 2022 and expects to seek regulatory approval in the UK and US in due course.
